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Found 6 results
510(k) Data Aggregation
K Number
K172508Device Name
Ageless Health Medical Digital Thermometer
Manufacturer
Ageless Health Industrial Co., Ltd
Date Cleared
2018-08-08
(352 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Ageless Health Industrial Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ageless Health Medical Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. lt can be used for axillary measurement, oral measurement and rectal measurement.
Device Description
Ageless Health Medical Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermos sensor and ASIC technology. A thermistor is used as thermos sensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.
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K Number
K172895Device Name
AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819
Manufacturer
Ageless Health Industrial Co., Ltd
Date Cleared
2018-06-18
(269 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Ageless Health Industrial Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.
Device Description
AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
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K Number
K153552Device Name
AGE Automatic Upper Arm Blood Pressure Monitor
Manufacturer
Ageless Health Industrial Co., Ltd
Date Cleared
2016-06-01
(173 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Ageless Health Industrial Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is six sizes.
AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Device Description
AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
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K Number
K152508Device Name
Ageless Health Medical Digital Thermometer
Manufacturer
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
Date Cleared
2015-12-31
(120 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
DONGGUAN AGELESS HEALTH INDUSTRIAL CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral).
Device Description
Ageless Health Medical Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.
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K Number
K151281Device Name
AGE Automatic Wrist Blood Pressure Monitor
Manufacturer
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
Date Cleared
2015-06-30
(47 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
DONGGUAN AGELESS HEALTH INDUSTRIAL CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm~19.5cm.
Device Description
AGE Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
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K Number
K123882Device Name
AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
Manufacturer
AGELESS HEALTH INDUSTRIAL
Date Cleared
2013-08-14
(240 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
AGELESS HEALTH INDUSTRIAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 24~34 cm.
Device Description
AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the oscillometric technique. The device also has low voltage indication, which will be triggered when the battery is low.
Ask a Question
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